Trial · NCT00349908
A Feasibility Study of the Cordis Neurovascular Self Expanding Stent System in Intracranial Arteries
NCT00349908, Phase 1, Completed, Codman & Shurtleff; results first posted 2013-10-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Feasibility Study of the Cordis Neurovascular Self Expanding Stent System in Intracranial Arteries. Trials, record NCT00349908. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00349908
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Feasibility Study of the Cordis Neurovascular Self Expanding Stent System in Intracranial Arteries
- NCT number
- NCT00349908
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 20 participants, actual
- Lead sponsor
- Codman & Shurtleff
- Conditions
- Atherosclerosis, Aneurysm
- Interventions
- Cordis Neurovascular ENTERPRISE Self Expanding Stent System, Cordis Neurovascular ENTERPRISE Self Expanding Stent System
- First posted
- 2006-07-10
- Last updated
- 2014-06-30
- Results first posted
- 2013-10-11
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Technical Feasibility- Successful Stent/Coil Placement (Post Procedure) | post procedure | Successful placement of the product assessed immediately post procedure |
| Primary | Technical Feasibility- Percent Occlusion (Post Procedure) | post procedure | Occlusion evaluated immediately post procedure |
| Primary | Technical Feasibility- Percent Occlusion (6 Mo Post Procedure) | 6 mo | 6 Months post |
| Primary | Technical Feasibility- Successful Stent/Coil Placement (6 Mo Post Procedure) | 6 mo | Successful stent/coil placement assessed at 6 mo post |
| Primary | Technical Feasibility- Percent Stenosis (6 mo Post Procedure) | 6 mo | Percent Stenosis assessed 6 mo Post Procedure from pre-procedure |
| Primary | Technical Feasibility- Percent Stenosis (Post Procedure) | Post Procedure | Percent Stenosis assessed immediately post procedure from pre procedure |
| Secondary | The Secondary Outcome Measure in Group 1, Atherosclerosis and in Group 2, Aneurysm, is the Evaluation of Adverse Events. The Groups Were Analyzed Separately. | 6 months | An adverse event was defined as any untoward medical occurrence in a subject. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Technical Feasibility- Successful Stent/Coil Placement (Post Procedure) | post procedure | percentage of stable placement | NUMBER | |
| SECONDARY | The Secondary Outcome Measure in Group 1, Atherosclerosis and in Group 2, Aneurysm, is the Evaluation of Adverse Events. The Groups Were Analyzed Separately. | 6 months | Group 1 and Group 2 were analyzed separately. In group 1 Atherosclerosis, 25 unique adverse events were reported in 8 of the 10 eligible subjects. In group 2 aneurysm, 28 unique adverse events were reported in 9 of the 10 eligible subjects. | Number of adverse events | NUMBER |
| PRIMARY | Technical Feasibility- Percent Occlusion (Post Procedure) | post procedure | Group 1 - Atherosclerosis Arm not analyzed for occlusion. Occlusion only relevant in Aneurysm treatment. | percent occlusion | MEAN |
| PRIMARY | Technical Feasibility- Percent Occlusion (6 Mo Post Procedure) | 6 mo | Group 1 - Atherosclerosis Arm not analyzed for occlusion. Occlusion only relevant in Aneurysm treatment. | percent occlusion | MEAN |
| PRIMARY | Technical Feasibility- Successful Stent/Coil Placement (6 Mo Post Procedure) | 6 mo | Percentage of stable stent/coil placemen | NUMBER | |
| PRIMARY | Technical Feasibility- Percent Stenosis (6 mo Post Procedure) | 6 mo | Group 2 - Aneurysm Arm not analyzed for stenosis. Stenosis only relevant in Atherosclerosis treatment. | Percentage change from PreProcedure | MEAN |
| PRIMARY | Technical Feasibility- Percent Stenosis (Post Procedure) | Post Procedure | Group 2 - Aneurysm Arm not analyzed for stenosis. Stenosis only relevant in Atherosclerosis treatment. | Percentage Change from PreProcedure | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Technical Feasibility- Successful Stent/Coil Placement (Post Procedure) | Group 1 | 100 | 47.3 | percentage of stable placement | |
| Technical Feasibility- Successful Stent/Coil Placement (Post Procedure) | Group 2 | 90 | 14.7 | percentage of stable placement | |
| The Secondary Outcome Measure in Group 1, Atherosclerosis and in Group 2, Aneurysm, is the Evaluation of Adverse Events. The Groups Were Analyzed Separately. | Group 1 | 25 | Number of adverse events | ||
| The Secondary Outcome Measure in Group 1, Atherosclerosis and in Group 2, Aneurysm, is the Evaluation of Adverse Events. The Groups Were Analyzed Separately. | Group 2 | 28 | Number of adverse events | ||
| Technical Feasibility- Percent Occlusion (Post Procedure) | Group 2 | 86.8 | Full Range 0 to 100 | percent occlusion | |
| Technical Feasibility- Percent Occlusion (6 Mo Post Procedure) | Group 2 | 88.8 | Full Range 0 to 100 | percent occlusion | |
| Technical Feasibility- Successful Stent/Coil Placement (6 Mo Post Procedure) | Group 1 | 100 | Percentage of stable stent/coil placemen | ||
| Technical Feasibility- Successful Stent/Coil Placement (6 Mo Post Procedure) | Group 2 | 100 | Percentage of stable stent/coil placemen | ||
| Technical Feasibility- Percent Stenosis (6 mo Post Procedure) | Group 1 | -47.3 | Standard Deviation 21.2 | Percentage change from PreProcedure | |
| Technical Feasibility- Percent Stenosis (Post Procedure) | Group 1 | -38.5 | Standard Deviation 18.3 | Percentage Change from PreProcedure |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aneurysm Arm | 10 | |
| Overall Study | STARTED | Atherosclerosis Arm | 10 | |
| Overall Study | COMPLETED | Aneurysm Arm | 10 | |
| Overall Study | COMPLETED | Atherosclerosis Arm | 6 | |
| Overall Study | NOT COMPLETED | Aneurysm Arm | 0 | |
| Overall Study | NOT COMPLETED | Atherosclerosis Arm | 4 |
Source ClinicalTrials.gov
Adverse events80
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Group 1: Atherosclerosis Arm | 3 | 10 | 3 |
| other | Headache | Nervous system disorders | Group 2: Aneurysm Arm | 8 | 10 | 8 |
| other | Hematoma | Nervous system disorders | Group 1: Atherosclerosis Arm | 1 | 10 | 1 |
| other | Hematoma | Nervous system disorders | Group 2: Aneurysm Arm | 1 | 10 | 1 |
| other | Hypo-Hypertension | Blood and lymphatic system disorders | Group 1: Atherosclerosis Arm | 3 | 10 | 3 |
| other | Hypo-Hypertension | Blood and lymphatic system disorders | Group 2: Aneurysm Arm | 0 | 10 | 0 |
| other | Ischemia | Nervous system disorders | Group 1: Atherosclerosis Arm | 1 | 10 | 1 |
| other | Ischemia | Nervous system disorders | Group 2: Aneurysm Arm | 0 | 10 | 0 |
| other | Myocardial Infarction | Nervous system disorders | Group 1: Atherosclerosis Arm | 1 | 10 | 1 |
| other | Myocardial Infarction | Nervous system disorders | Group 2: Aneurysm Arm | 0 | 10 | 0 |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1: Atherosclerosis Arm | ||
| Total, all-cause mortality | Group 2: Aneurysm Arm | ||
| Total, other adverse events | Group 1: Atherosclerosis Arm | 8 | 10 |
| Total, other adverse events | Group 2: Aneurysm Arm | 9 | 10 |
| Total, serious adverse events | Group 1: Atherosclerosis Arm | 3 | 10 |
| Total, serious adverse events | Group 2: Aneurysm Arm | 3 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Group 1: Atherosclerosis Arm vs Group 2: Aneurysm Arm: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00349908
GET https://conductscience.org/api/trials/v1/NCT00349908/events?page=2